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NCT06410300 | RECRUITING | Lung Cancer

Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Sponsor:

B OL U

Information provided by (Responsible Party):

B OL U

Brief Summary:

The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

Condition or disease

Lung Cancer

Intervention/treatment

Curative Radiotherapy

Immunotherapy

Detailed Description:

This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.

Study Type : OBSERVATIONAL
Estimated Enrollment : 125 participants
Official Title : A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Actual Study Start Date : 2024-04-19
Estimated Primary Completion Date : 2028-04-19
Estimated Study Completion Date : 2030-04-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient older than 18 years age
  • * Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.
  • * Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.
  • * Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.
  • * ECOG performance status of 0-2
  • * Life expectancy of 6 months or longer
  • * Patient able to provide a written informed consent prior to study entry
Exclusion Criteria
  • * Prior thoracic radiotherapy to chest.
  • * Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.
  • * Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

Location Details

NCT06410300

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Missouri

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, United States, 65212

NOT YET RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901

NOT YET RECRUITING

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642